ComplyKart Services
ISO 13485 Certification — Done Right, Without the Runaround
Quality certification for medical device makers, audit-ready from day one
CA/CS-guided review
Your documents and structure are checked before anything is filed.
Written scope first
Inclusions and payable charges are explained before work begins.
Support till it’s done
One team owns your filing, from the first call to the final handover.
Plans from ₹39,999
Pick the plan that fits the stage of your business. Any variable government charges are shown in a written breakup before filing.
Get a free callback
Your details stay private — we only call about this enquiry.
Experience behind every filing
A quick snapshot of the work so far.
Fees
Fees and packages for ISO 13485 Certification
Pick the plan that fits the stage of your business. Every plan starts with a written breakup — no surprises later.
Choose a plan to prefill the callback form.
🤔 Not sure which plan fits you?
Two quick questions. We'll tell you which plan actually fits.
1. How soon do you need this done?
Standard (up to 25 employees)
₹39,999
What’s included
- Gap analysis of your current practices, with a written report
- Complete documentation set: manual, procedures, formats and records
- One-day on-site training for your team
- Internal audit by our team before the certification audit
- Support for the management review meeting
- Coordination with the certification body for Stage 1 and Stage 2 audits
- Help closing any non-conformities the auditor raises
- Certification body audit fees charged separately at actuals
Growth (26–100 employees)
₹59,999
What’s included
- Everything in Standard
- Department-wise documentation for each function
- Two-day training across shifts
- Two internal audit rounds before certification
- Support through the first surveillance audit
- Certification body audit fees charged separately at actuals
Done right, or your money back.
If our experts find your requirement can't be fulfilled as scoped, you get a full refund of the professional fee — no questions, no fine print. Government charges already paid are pass-through and go to the government, not us.
Every quote shows the professional fee, government charges and taxes as separate lines — you approve the full breakup in writing before paying anything.
Stamp duty, filing fees and department charges go to the government, not to us. They vary by state, capital and applicant count, so we show them separately for your case.
The free consultation comes first. You only pay after you have seen the exact scope, the exact breakup and the expected timeline — no surprises later.
1
Free consultation. Tell us what you need; a CA, CS or advocate maps the exact scope.
2
Written quote. You receive the plan, the line-by-line breakup and the timeline in writing.
3
You approve, then pay. Work starts only after you sign off on the quote.
You know exactly which filings, documents and handover items belong to your selected plan.
Capital, stamp duty, applicant count and case-specific government charges are shown separately.
Choose the tier around the way you plan to operate, not simply the highest price.
Overview
What ISO 13485 Means For Your Business
ISO 13485 is the quality management standard for medical devices. It covers design, production, installation, and servicing of medical devices.
CDSCO licences and most export orders require it. Without it, device makers struggle to sell at home or abroad.
The certificate is issued by an accredited certification body after a two-stage audit. We build your quality system and get you ready for that audit.
Benefits
Why Device Makers Choose ISO 13485
Open each benefit to see what it means for you.
CDSCO licence support
A working quality system strengthens your CDSCO licence applications and inspections.
Export market access
International buyers and regulators treat ISO 13485 as the entry ticket for medical devices.
Controlled production
Documented processes cut batch failures and complaints. Every batch stays traceable.
Faster tender approvals
Government and hospital tenders favour certified manufacturers. Your bids carry more weight.
Documents
Documents You Will Need
Clear, current documents matter more than a long checklist. Names, dates of birth and addresses should match across records.
0 documents marked ready
Tick what you already have. This checklist resets when you leave the page.
Quality system records
Compliance records
Process
How We Prepare You
You’ll see each stage, what’s pending and what we need from you — so filings don’t bounce back.
Step 1 of 5
Gap analysis
We assess your facility against ISO 13485 clause by clause. You get a prioritised list of what must change.
Documentation
We draft your quality manual, procedures, and device records. Everything is written to match your actual production.
Staff training
We train your production, quality, and management teams on the system. Records of training are kept for the audit.
Internal audit
We conduct a full internal audit before certification. Nonconformities are closed so the external audit runs clean.
Certification audit support
We coordinate with the accredited body and support you through Stage 1 document review and the Stage 2 on-site audit.
Why ComplyKart
How ComplyKart helps
You should know who’s doing what. Open a stage to see how the work is shared.
Regulated-industry experience
We work with device and pharma manufacturers who live under regulatory inspections. We know what auditors expect.
Documentation that survives audits
Your records are written for real production floors, not for show. They hold up under CDSCO and certification audits ali...
Audit-day support
We stay with you through both stages of the certification audit. You answer the auditor with us beside you.
Regulated-industry experience: We work with device and pharma manufacturers who live under regulatory inspections. We know what auditors expect.
If a founder or investor is outside India
Foreign ownership is possible in many sectors, but it adds document authentication, banking and FEMA work. Set the route before funds move.
Plan before you start
- Check whether your sector permits automatic-route foreign investment
- Confirm the Indian resident director arrangement
- Map ownership, beneficial ownership and pricing
- Allow time for apostilled or consularised documents
Plan for after setup
- Receive funds through permitted banking channels
- Complete RBI/FEMA reporting and keep the bank evidence
- Coordinate tax and ongoing compliance advice early
FAQ
ISO 13485 FAQs
Search all 5 answers, or filter by the stage you’re thinking about.
Showing 5 of 5 answers
No. Only an accredited certification body issues the certificate after an audit. We prepare your quality system and coordinate the audit.
CDSCO looks for a working quality system when licensing device makers. ISO 13485 certification is the recognised way to demonstrate it.
Most units are ready in 3 to 6 months. The timeline depends on your current documentation and production controls.
Stage 1 reviews your documents. Stage 2 is the on-site audit of how your quality system works in actual production.
Three years, with yearly surveillance audits by the certification body to confirm continued compliance.
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What clients say about working with us
Real stories from businesses we've worked with.
Our Trademark was applied in all the classes with a short span of time by Complykart Trademark Experts and I can say the level of expertise and commitment they carry is remarkable. It's an A+ from my side. We are now sticking to ComplyKart only.
I found the professionalism of the staff at complykart.com, a pleasure to work with. As a foreigner to India, they took the time to explain the documentation and assisted in every question I raised. I was pleased that complykart.com made it easy for my Business.
Trust, Commitment, Dedication and responsiveness are the best things with ComplyKart. Thanks for handling our Merger assignment with so much care. After my business disputes, complykart handles all things with own sense of understanding.
Trust & transparency
Sources & how we keep this page accurate
Primary sources we refer to:
- Ministry of Corporate Affairs (MCA)
- GST Portal
- Income Tax Department
- IP India (Trademark / Patent / Copyright)
Last verified: 4 October 2026
Compliance rules change. If something on this page looks outdated, tell us on WhatsApp and we'll fix it — and your filing will always follow the current rules, not just what's written here.
Get a free consultation
Talk to a ComplyKart professional about ISO 13485 Certification. The first consultation is free.
